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FDA 510(k)

MINXRAY, MODELS HFP24 AND HFP40

K-Number: K060566 · 2006-04-05

ApplicantMikasa X-Ray Co., Ltd.
Decision Date2006-04-05
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINXRAY, MODELS HFP24 AND HFP40 is the device name listed in this FDA 510(k) record. The listed applicant is Mikasa X-Ray Co., Ltd.. It received FDA 510(k) clearance on 2006-04-05 under 510(k) number K060566. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINXRAY, MODELS HFP24 AND HFP40?

MINXRAY, MODELS HFP24 AND HFP40 is a medical device that received FDA 510(k) clearance on 2006-04-05. The listed applicant is Mikasa X-Ray Co., Ltd.. The 510(k) number is K060566.

When did MINXRAY, MODELS HFP24 AND HFP40 receive FDA 510(k) clearance?

MINXRAY, MODELS HFP24 AND HFP40 received FDA 510(k) clearance on 2006-04-05, under 510(k) number K060566.

Who is the listed applicant for MINXRAY, MODELS HFP24 AND HFP40?

The FDA 510(k) record lists Mikasa X-Ray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINXRAY, MODELS HFP24 AND HFP40?

The FDA product code for MINXRAY, MODELS HFP24 AND HFP40 is IZL.

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Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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